An implantable prosthetic heart valve is used as a replacement for an excised native heart valve of a patient. A typical prosthetic heart valve includes an annular valve body to provide a passageway for blood flow. At least one, and usually two, leaflets or occluders are mounted to an inner surface of the annular valve body and open or close with the flow of blood through the passageway.
A suture ring or sewing cuff is used to sew the prosthetic heart valve to the patient's heart tissue. The sewing cuff is placed proximate the tissue annulus at the site of the excised native heart valve. The sewing cuff is secured about the annular valve body in a circumferential groove and generally includes a biocompatible fabric that allows a needle and a suture to pass through.
Holders have been developed to assist in the implantation of the prosthetic heart valve. One such holder includes two jaws linked by a hinge. Flanges on a distal end of each jaw form arcuate channels that are inserted into the passageway of the annular valve body to engage an inner circumferential surface of the annular valve body. A suture is then tied tightly around proximal ends of the jaws to hold the jaws together so that the distal ends are extended and the flanges engage the annular valve body. When the suture is cut, one or both of the jaws pivot on the hinge to move the flanges together and thereby disengage from the inner circumferential surface of the annular valve body. In this position, the holder can be retracted from the prosthetic heart valve.
Once the suture has been cut, it is quite difficult, time consuming, and in some cases impossible to reattach the prosthetic heart valve to the holder. In addition, when the suture is cut, the surgeon must ensure that the holder and suture is removed
For convenience, a prosthetic heart valve and its associated holder are commonly assembled by the manufacturer and shipped in a sterile enclosure. To prevent damage to the prosthetic heart valve during shipping and handling, the assembly must form a stable structure. During shipping, the suture can elongate, become untied, or even break. When this occurs, the prosthetic heart valve may dislodge from the holder and could be damaged.